An observational study in TAVI(Transcatheter Aortic Valve Implantation), TAVI and Quality of Life, sponsored by University Hospital Plymouth NHS Trust. Not yet recruiting at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by University Hospital Plymouth NHS Trust · Observational
Transcatheter aortic valve implantation (TAVI) has become an important therapeutic intervention for patients with symptomatic severe aortic stenosis (AS) who are at high surgical risk. While the clinical outcomes of TAVI are well established, there is limited data on the long-term quality of life (QoL) following the procedure. This prospective study will assess QoL in patients undergoing TAVI at Derriford Hospital, University Hospitals Plymouth, UK. Investigators will employ the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and Mini-Montreal Cognitive Assessment (Mini-MoCA) to evaluate both physical and mental health outcomes, supplemented by an analysis of life expectancy estimated by a multidisciplinary team (MDT). Data will be collected at referral, pre-procedural, 30 days, and 3 months post-TAVI. This will be the first prospective trial focused on QoL improvement after TAVI, as all previous studies have been retrospective in nature. The study aims to provide comprehensive insights into the QoL improvements after TAVI, which will guide future clinical decision-making in this population.
Study Title uality of Life Improvement after Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK trial)
Study Design This is a prospective, single-center study that will be conducted over 1 year at Derriford Hospital, University Hospitals Plymouth, UK.
Study Participants The study will include all patients undergoing TAVI for severe AS during this period.
Eligibility Criteria Inclusion Criteria: Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.
Exclusion Criteria: Patients who declined enrollment in this research.
Planned Sample Size More than 100 patients
Follow-up Duration 3 months
Planned Study Period 1 year
Primary Objective This study aims to address the knowledge gap regarding the impact of TAVI on Quality of Life (QoL) Secondary Objective -
971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.
This study's planned enrollment of 100 is below the median of 235 across 131 observational studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →University Hospital Plymouth NHS Trust is the lead sponsor of 53 studies on the registry; 7 are open to participants now.
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Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.
Exclusion Criteria:
Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.
Behavioral: Quality of Life
Measures - We will use the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) to assess QoL, Mini-Montreal Cognitive Assessment (Mini-MoCA) to assess cognitive function, the Clinical Frailty Scale (CFS) to assess frailty status, and life expectancy estimation by the heart team to categorize patients as having: 1-2 years expected survival or more than 2 years expected survival (This will allow for an analysis of how life expectancy correlates with QoL improvements after TAVI). Assessment Timeline - Patients will be assessed at four key time points: at time of referral (baseline assessment), pre-procedure (to assess impact of delay on the patient), 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI (longer-term follow-up to evaluate sustained QoL changes). At each time point, the KCCQ-12, Mini-MoCA, and Clinical Frailty Scale (CFS) will be administered.
Also known as: KCCQ-12, CFS, Mini-MoCA
Improvement of QoL
This is defined as improvement in QoL scores from baseline to 3 months post-TAVI. Based on KCCQ-12, a change of 5 points (small but clinically important change), 10 points (moderate-to-large), and 20 points (large-to-very large clinical changes). Based on CFS score, worsened frailty is defined as an increase in CFS score of +4, and improved frailty by a decrease of -2.
Time frame: 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI
Correlation between life expectancy and QoL improvements
Correlation between life expectancy and QoL improvements using regression analysis. Mental health and cognitive function (Mini-MoCA scores), frailty status (CFS), will be explored as potential mediators of QoL outcomes.
Time frame: 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI
Plan to share: Yes — Relevant information related to the study will be shared
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University Hospital Plymouth NHS Trust